Frequent Standardized Oral Care to Improve Health Outcomes in Premature Infants in the Neonatal Intensive Care Unit

University of Florida

Status: Active, not recruiting

Conditions: Ventilator Associated Pneumonia; Microbial Colonization

Treatments: Other: frequent standardized oral care

Study type: Interventional

Funder types: Other

Identifiers

NCT05167318

IRB202101340

Details and patient eligibility

About

Premature very low birth weight (VLBW) infants are susceptible to complications related to infrequent and non-standardized oral care. Although the benefits of frequent standardized oral care are known to reduce oral dybiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for VLBW infants. The proposed study will prospectively follow 40 VLBW infants for 4 weeks following birth. Infants will be randomized into 1 of 2 groups. Standardized oral care will be performed every 3-4 hours (Group 1) and every 12 hours (Group 2). Aim 1 will evaluate the feasibility of frequent standardized oral care, Aim 2 will compare the oral microbiome between groups, and Aim 3 will compare respiratory outcomes including the incidence of ventilator associated pneumonia, bronchopulmonary dysplasia and need for respiratory support between infants receiving standardized oral care every 3-4 hours and every 12 hours. Issues related to recruitment, retention, randomization, acceptance by nursing staff, and treatment fidelity will be examined. Saliva samples will be obtained weekly and analyzed using 16S sequencing, respiratory cultures will be obtained weekly on ventilated infants, and respiratory outcomes will be collected from the medical records.

Enrollment: 150 patients

Sex: All

Ages: 12 to 72 hours old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age < 32 weeks
• birth weight < 1500 grams
• mother is English speaking
• mother is > 18 years of age.

Exclusion criteria

• Congenital anomalies of the face, lungs, or gastrointestinal system
• not expected to survive

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

every 3-4 hour oral care

Experimental group

Description:

Infants will receive standardized oral care every 3-4 hours for 4 weeks

Treatment:

Other: frequent standardized oral care

every 12 hour oral care

No Intervention group

Description:

Infants will receive standardized oral care every 12 hours for 4 weeks